USP Chapter Focus on Approaches to Addressing ...exposure • Documented health effects due to exposure – Acute: skin rash, eye or throat irritation, nausea – Chronic:
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USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in
Healthcare Settings
Patricia C. Kienle, B.S.Pharm., M.P.A., FASHPCardinal Health Innovative Delivery Solutions
Wilkes‐Barre, Pennsylvania
Wendy R. Gaudet, Pharm.D.Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana
Chun‐Yip Hon, Ph.D., CPHI(C), CRSP, CIHSchool of Occupational and Public Health
Ryerson UniversityToronto, Ontario
Provided by ASHPSupported by an educational grant from BD 1.5 hr
In accordance with ACCME and ACPE Standards for Commercial Support, ASHP policy requires that all faculty, planners, reviewers, staff, and others in a position to control the content of this presentation disclose their financial relationships. In this activity, only the individual below has disclosed a relevant financial relationship. No other persons associated with this presentation have disclosed any relevant financial relationships.• Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
At the conclusion of this activity, participants should be able to• Review the status of the section in USP Chapter <800>pertaining to environmental quality and control
• Describe the evidence related to surface contaminationand where it occurs in healthcare systems
• Describe approaches and emerging technologies forprotecting healthcare workers from exposure tohazardous drugs (HDs)
• Explain key elements of a surface wipe sampling plan
Learning Objectives
USP Chapter <800>: What’s in It for Me?
Patricia C. Kienle, B.S.Pharm., M.P.A., FASHPDirector, Accreditation and Medication SafetyCardinal Health Innovative Delivery Solutions
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
What Is Surface Contamination?
• Absorption through skin can result in systemic exposure
• Documented health effects due to exposure– Acute: skin rash, eye or throat irritation, nausea– Chronic: reproductive health risks, genetic damage
Connor TH et al. CA Cancer J Clin. 2006; 56:354‐65.NIOSH. NIOSH alert: preventing occupational exposures to antineoplastic and other hazardous drugs in health care
settings. 2004. http://www.cdc.gov/niosh/docs/2004‐165/pdfs/2004‐165.pdf (accessed 2018 Oct 26).
• The meta‐analysis of micronuclei frequency from 24 studies confirmed an association between occupational exposure to antineoplastic drugs and cytogenetic effects with an overall meta‐estimate of 1.67 [95% CI: 1.41–1.98]
Villarini M et al. Mutat Res. 2016; 770(PtA):35‐45.
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
• A meta‐analysis confirmed a significant association between occupational exposure to antineoplastic drugs during the course of a normal work day and increases in chromosomal aberrations in healthcare workers
Roussel C et al. Mutat Res Rev Mutat Res. 2017 Aug 17 [Epub ahead of print]. https://doi.org/10.1016/j.mrrev.2017.08.002 (accessed 2018 Oct 30).
Evidence of Health Effects
Results from the Literature
https://scholar.google.ca/scholar?q=hazardous+drug+%2B+surface+contamination&hl=en&as_sdt=0%2C5&as_ylo=2013&as_yhi= (accessed 2018 Oct 30).
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
Results from the Literature
• “Every published surface contamination study has identified at least one drug present by wipe sample analysis”
• 1 ng/cm2 has been suggested as a threshold of exposure for cyclophosphamide only in USP Chapter <800>– Based on work of one research team – Sessink et al.
USP chapter <800> hazardous drugs: handling in healthcare settings. U.S. Pharmacopeial Convention, 2018.Sessink PJ et al. Hosp Pharm. 2013; 48:204‐12.
Connor TH et al. J Occup Environ Med. 2010; 52:1019‐27.
• No established occupational exposure limits – No ACGIH threshold limit values (TLVs)– No OSHA permissible exposure limits (PELs) – No NIOSH recommended exposure limits (RELs)
• Suggested ‘hygienic guidance values’ developed in other countries
Occupational Exposure Limits?
ACGIH = American Conference of Governmental Industrial HygienistsOSHA = Occupational Safety and Health Administration
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
• Since there are no occupational exposure limits, the ALARA principle applies
Occupational Exposure Limits?
A LARA
sowseasonablychievable
• Wipe sampling is a suitable means to i) evaluate work practices, ii) evaluate the effectiveness of applied control measures, and iii) identify the risk for healthcare workers
Böhlandt A et al. Pharma Tech Hosp Pharm. 2016; 1:139‐50.
– Typically have two lines: 1) a test line that varies in intensity with the concentration of analyte and 2) a control line that is relatively constant and mainly used to assure that the cassette is working properly
• A cotton swab wetted in sampling buffer is used to wipe surface, and the swab is then extracted in 1 mL sampling buffer
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
• Studies are mixed regarding a correlation between the amount of drugs handled and the extent of surface contamination
• However, certain work practices result in a lower number of positive wipe samples, including routine monitoring
Factors Associated with Surface Contamination
• Long‐term evaluation of drug contamination with repeated monitoring seems beneficial to a) characterize the actual exposure and b) assess surface contamination over time
• Regular environmental monitoring is a good practice to maintain contamination as low as reasonably achievable
Böhlandt A et al. Pharm Tech Hosp Pharm. 2016; 1:139‐50.
Importance of Routine Monitoring
Roland C et al. J Occup Environ Hyg. 2017; 14:650‐8.
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
• Böhlandt A, Schierl R (2016). Benefits of wipe sampling: evaluation of long‐term 5‐fluorouracil and platinum monitoring data. Pharm Technol HospPharm. 2016; 1:139‐50.
• Connor TH, Smith JP. New approaches to wipe sampling methods for antineoplastic and other hazardous drugs in healthcare settings. Pharm Technol Hosp Pharm. 2016; 1:107‐14.
• Hon CY et al. Antineoplastic drug contamination of surfaces throughout the hospital medication system in Canadian hospitals. J Occup Environ Hyg. 2013; 10:374‐83.
• Hon CY et al. Occupational exposure to antineoplastic drugs: identification of job categories potentially exposed throughout the hospital medication system. Saf Health Work. 2011; 2:273‐81.
Selected Resources
Making Surface Sampling Work: Practical Issues to Address
Patricia C. Kienle, B.S.Pharm., M.P.A., FASHPDirector, Accreditation and Medication SafetyCardinal Health Innovative Delivery Solutions
• Environmental wipe sampling for HD surface residue should be performed routinely (e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment)
• Because of the growing number of assays available for HDs, surface wipe sampling … should be done to document the effectiveness of any agent used for decontamination of HD residue from work surfaces
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
• 2018 ASHP Guidelines on Handling Hazardous Drugs– Section on environmental sampling for HDs
ASHP Guidelines
Am J Health‐Syst Pharm. Published online ahead of print October 16, 2018.http://www.ajhp.org/content/early/2018/10/11/ajhp180564 (accessed 2018 Oct 30).
NIOSH list of antineoplastics and other hazardous drugs in healthcare settings.
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
Key Elements of a Wipe Sampling Plan
What is your organization’s biggest challenge to implementing a wipe sampling program?a. Cost b. Awareness of why it needs to be donec. Cultural acceptance d. Already implemented or no challengese. Not in practice
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
• Used mass spectrometry wipe sampling kits– Collected baseline samples in all pharmacies and high risk administration areas
Our New Wipe Sampling Plan
Pharmacy Locations Administration Locations
• Hood surfaces• Hood foils• Floors adjacent to hoods• Computers in cleanrooms• Pass‐through chambers• Order entry stations• ADC bins
• IV poles• Floor under IV poles• Area near HD yellow waste bins• Work stations on wheels• Medication room storage bins• Charge nurse desk• Patient rooms
• Results reported to HDTF• Walked through the entire process to identify gaps and opportunities for improvement
• Frontline staff brainstormed on what success should look like – Rewrote standard operating procedures and re‐educated staff– Considered scheduling with semi‐annual certification due dates
– Incorporated and scheduled wipe sampling task into IV workflow software
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
• New study with lateral flow immune assay (LFIA)– Need quicker validation of SOPs
• Working with HDTF on possible uses of rapid testing in conjunction with mass spectrometry– Spills– Spot checking by Environmental Services in high risk patient rooms and procedural areas
– Incorporate in competency check off during training and at least annually thereafter
– Random checks to validate safe handling program• Identifying and tracking any trends
What We Are Considering
• Awareness and cultural acceptance are keys to a successful wipe sampling program
• Work with vendors for sponsoring projects to help promote your plan
• Perfect processes are a moving target • Barriers are a mere obstacle; keep pushing “The Why”
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
Assessment Questions
1. What method of environmental monitoring can detect hazardous drugs that have escaped containment?
a. Settling plates b. Air sampling c. Wipe sampling d. Gloved fingertip testing
2. Chronic health effects due to exposure to surfaces contaminated with hazardous drugs include all of the following EXCEPT
a. Miscarriage b. Inability to conceive c. Genetic damage d. Nausea
3. What level of contamination has typically been found in studies identifying surface contamination of hazardous drugs in health systems?
a. mg/cm2 b. µg/cm2 c. ng/cm2 d. pg/cm2
4. What is the current acceptable occupational exposure limits for hazardous drugs? a. Undetectable at pg level b. 10 ng/cm2 c. Hygienic guidance values developed in other countries d. As low as reasonably achievable
5. Which of the following best describes the usefulness of wipe sampling in health systems? a. Evaluate work practices, evaluate the effectiveness of applied control measures, and identify
the risk for healthcare workers b. Evaluate work practices, identify the risk for healthcare workers, and comply with the USP
<800> monitoring requirement c. Evaluate the effectiveness of applied control measures, identify the risk for healthcare
workers, and comply with the USP <800> monitoring requirement d. Evaluate the effectiveness of applied control measures, identify areas of microbial
contamination, and evaluate work practices
6. Compared with traditional wipe sampling, newer wipe sampling methods using lateral flow immune assay (LFIA) have the advantage of
a. Provision of quantitative results b. Provision of results in minutes c. Ability to detect multiple drugs with a single swab d. Lower limit of detection
USP Chapter <800>: Focus on Approaches to Addressing Surface Contamination in Healthcare Settings
7. According to USP Chapter <800>, environmental wipe sampling for hazardous drug surface residue
should be conducted at least every a. Month b. 3 months c. 6 months d. 12 months
8. A reasonable goal for a health system that has established a routine monitoring plan for hazardous
drugs every 6 months (samples collected in drug preparation, storage, and administration areas) would be to have no detectable levels in at least 50% of samples collected.
a. True b. False
9. As described by Dr. Gaudet, what was the value of conducting an 8‐week study of hazardous drug
contamination at her hospital that consisted of multiple wipe samples once weekly in the same locations?
a. Identified problems with 5‐fluorouracil (5‐FU) contamination and pinpointed the source of the problem
b. Identified problems with contamination from multiple hazardous drugs and pinpointed the source of the problem
c. Identified problems with 5‐FU contamination and stimulated internal investigation to identify the source of the problem and associated process gaps
d. Identified problems with contamination from multiple hazardous drugs and stimulated internal investigation to identify the source of the problem and associated process gaps
10. When developing a surface wipe sampling plan, which of the following potential uses of rapid testing
monitoring would be most valuable when training staff on procedures for safe handling of hazardous drugs?
a. Incorporate in competency check during training and at least annually thereafter b. Conduct random checks in varied areas of the facility c. Conduct spot checks in high risk patient rooms and procedural areas d. Verify appropriate cleaning and decontaminating after a spill occurred
Patricia C. Kienle, B.S.Pharm., M.P.A, FASHP, Activity ChairDirector, Accreditation and Medication Safety Cardinal Health Innovative Delivery Solutions Wilkes-Barre, Pennsylvania
Patricia C. Kienle, B.S.Pharm., M.P.A., FASHP, is Director of Accreditation and Medication Safety for Cardinal Health Innovative Delivery Solutions in Wilkes-Barre, Pennsylvania. She received her pharmacy degree from Philadelphia
College of Pharmacy and Science and a Master in Public Administration degree from Marywood University in Scranton, Pennsylva-nia. She completed the Executive Fellowship in Patient Safety from Virginia Commonwealth University and is Adjunct Associate Professor at Wilkes University in Wilkes-Barre.
Ms. Kienle has served on the ASHP Board of Directors and as President of the Pennsylvania Society of Health-System Pharmacists. She is a fellow of ASHP and received the ASHP Dis-tinguished Leadership Award. She has served on the Pharmacotherapy Specialty Council of the Board of Pharmaceutical Specialties, Pennsylvania Patient Safety Authority, Hospital Professional and Technical Advisory Com-mittee of The Joint Commission, and Board of Governors of the National Patient Safety Foundation. She is a member of the USP Compounding Expert Committee and chair of the Subcommittee on Hazardous Drugs.
Ms. Kienle is co-author of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide,8th Edition and author of The Chapter <800> Answer Book. She frequently givespresentations on medication safety, compounding sterile preparations, accreditation, and regulatory issues.
Chun-Yip Hon, Ph.D., CPHI(C), CRSP, CIHAssociate Professor School of Occupational and Public Health Ryerson University Toronto, Ontario
Chun-Yip Hon, Ph.D., CPHI(C), CRSP, CIH, is Associate Professor with the School of Occupational and Public Health at Ryerson University in Toronto, Ontario, Canada. He has been with the
department since 2012 after receiving his Doctor of Philosophy degree in Occupational and Environmental Hygiene from the University of British Columbia.
Dr. Hon has participated in several occupational health studies based in the healthcare sector, with a focus on understanding healthcare workers’ exposure to chemotherapy (hazardous) drugs. To date, he has a dozen publications in this subject area, some of which have been referenced in best practice documents. Generally speaking, Dr. Hon’s research interests are occupational exposure assessments, risk assessment methods, and evaluation of intervention measures to prevent occupational exposure.
Dr. Hon has nearly 20 years of experience as an occupational hygienist, including working at a large health authority in the province of British Columbia. In addition, he possesses designations as a Certified Industrial Hygienist (CIH) and as a Canadian Registered Safety Professional (CRSP).
Wendy R. Gaudet, Pharm.D.LSU Health Baton Rouge, OLOL Livingston, and MBP-OLOL Cancer Center Our Lady of the Lake Regional Medical Center Baton Rouge, Louisiana
Wendy R. Gaudet, Pharm.D., is Director of Pharmacy for three divisions within Our Lady of the Lake (OLOL) Regional Medical Center in Baton Rouge, Louisiana: LSU Health Baton Rouge, OLOL Livingston, and Mary Bird Perkins-OLOL Cancer
Center. Her direct responsibilities are pharmacy operations for physician clinics, outpatient surgery, imaging and infusion centers, and two stand-alone emergency room departments and urgent care facilities.
Dr. Gaudet serves on multiple hospital and system committees and chairs the Franciscan Ministries of Our Lady Health System Hazardous Drug Task Force System Committee, as well as the OLOL Hazardous Drug Task Force Local Committee. She also serves on a statewide work group with Louisiana Hospital Association for medical marijuana in the healthcare setting.
Dr. Gaudet earned her Bachelor of Science degree at University of Arkansas at Monticello and her Doctor of Pharmacy degree from University of Louisiana at Monroe.
Dr. Gaudet is a member of ASHP and Louisiana Society of Health-System Pharmacists. Among her recognitions are the 2018 Baton Rouge Business Report’s Top 40 Under 40, 2017 Mother Gertrude Hennessy Leadership Award, 2017 Proven Leader Program of OLOL, Class of 2015 Baton Rouge Area Chamber Leadership Program, and 2007 President’s Award at Baton Rouge General Hospital.
About the Faculty
www.ashpadvantagemedia.com/hdmonitoring
Accreditation
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
n ACPE #: 0204-0000-18-439-H07-P n ACPE #: 0204-0000-18-439-H07-T n 1.5 contact hours I Knowledge-based n Qualifies for compounding CPE
US800_Contam_HdbkCov.indd 2 11/16/18 1:14 PM
Release Date: March 1, 2019 Expiration Date: April 27, 2021